CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 721 enrolled
Drug / intervention
Health Coachingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02124460
NCT02124460N/ACompleted

Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers

Massachusetts General Hospital·interventional·Posted Apr 28, 2014·Updated Apr 10, 2017

In Brief

A clinical study evaluating Health Coaching for Overweight and Obesity. Completed, enrolled 721 participants across 1 site.

Detailed Summary

Health care system (HCS)-based interventions have been limited by their inattention to social and environmental barriers that impede improvement in obesity-related behaviors. Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the organizational structure to provide longitudinal care for children with chronic illnesses, the clinicians to manage and support patients with chronic illnesses outside of clinic, and/or the health information systems that support the use of evidence-based practices at the point-of-care. Thus, the research question this study is designed to address is whether a novel approach to care delivery that leverages delivery system and community resources and addresses socio-contextual factors will improve family-centered childhood obesity outcomes. The primary specific aims are to examine the extent to which the intervention, compared to the control condition, results in: 1. A smaller age-associated increase in BMI over a 12-month period. 2. Improved parental and child ratings of pediatric health-related quality of life. The secondary aims are: 1. To examine parental ratings of quality and family-centeredness of pediatric obesity care and compare outcomes among participants in the intervention with the control condition 2. To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition 3. To assess the following process measures: * Reach * Extent of implementation * Fidelity to protocol * Parent satisfaction 4. To examine the extent to which neighborhood environments modify observed intervention effects 5. To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 28, 2014
Enrollment StartJun 1, 2014
Primary CompletionJun 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.2 years ago

Interventions

Health Coachingbehavioral

Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. During these visits, the health coach will coach the parent/child duos on improving obesity-related behaviors . The health coach will also help the family identify supports to assist with behavior change; discuss family health habits and the home environment; and review and encourage use of materials related to both specific target behaviors and available resources in the community. Following the first call with the health coach, parents will receive semi-weekly text messages designed by the study team. The messages will alternate in structure between 2 types of messages; 1) skills training messages will deliver tips and motivational messages to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond to the message and track health behaviors important to this study.